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| Sponsor: | University of Witwatersrand, South Africa |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | University of Witwatersrand, South Africa |
| ClinicalTrials.gov Identifier: | NCT00840905 |
Purpose
This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied.
Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.
| Condition |
|---|
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HIV HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil |
Blood /plasma specimen 10cc
| Estimated Enrollment: | 480 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa
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2
A cohort of HIV seropositive women from Gaborane Botswana
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3
A cohort of HIV seropositive women from Rio De Janeiro Brasil
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Plasma from HIV seropositive women will be taken and sent to MERCK in the USA to evaluate what the antibody titers of HPV 6,11,16 and 18. .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV seropositive women from South Africa, Botswana, and Brasil
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cynthia S Firnhaber, MD | 27-11-276-8800 | cfirnhaber@witshealth.co.za |
| Contact: Sophie Williams, BSc | 27-11-276-8800 | swilliams@witshealth.co.za |
| Botswana | |
| Shahin Lockman | |
| Habarone, Botswana | |
| Brazil | |
| Fundacao Oswaldo Cruz | |
| Rio De Janeiro, Brazil | |
| South Africa | |
| University of Witwatersrand/Helen Joseph Hospital | |
| Johannesburg, South Africa | |
| Principal Investigator: | Cynthia S Firnhaber, MD | Clinical HIV Research Unit University of Witwatersrand |
More Information
| Responsible Party: | Clinical HIV Research Unit ( Cynthia S Firnhaber Senior Investigator ) |
| Study ID Numbers: | Merck P0806 |
| Study First Received: | February 10, 2009 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00840905 History of Changes |
| Health Authority: | South Africa: Human Research Ethics Committee |
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HPV |
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Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |
